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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 28, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to BS ISO 13320-1: 1999 and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: BS ISO 13320-1: 1999
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KY-MA
- Appearance: white to light pink powder
- Storage condition of test material: at room temperature in the dark

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: MMAD: not determined(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
D50
Mean:
423.8 µm
St. dev.:
3.44
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
47.12 µm
Distribution:
< 10 %
Remarks on result:
other: 3.09% by volume of sample was seen to be ≤ 10 µm. Averages of 3 runs
No.:
#2
Size:
187.8 µm
Distribution:
< 25 %
Remarks on result:
other: Average of 3 runs
No.:
#3
Size:
423.8 µm
Distribution:
< 50 %
Remarks on result:
other: Average of 3 runs
No.:
#4
Size:
643.6 µm
Distribution:
< 75 %
Remarks on result:
other: Average of 3 runs
No.:
#5
Size:
784.4 µm
Distribution:
< 90 %
Remarks on result:
other: Average of 3 runs

Any other information on results incl. tables

Optical Microscope Analysis

- Standard visual observation: Sample observed to be a white to light pink, free-flowing, medium sized, powder with some lumps

- Observation at 100 x magnification: The particles appeared to be irregular shaped, sharp edged, crystals. The smallest particle size was approx. 9 μm and the largest size was 976 μm. The estimated mean was observed to be 400 μm.

- Observation at 400 x magnification: The sample was observed to be made up of single crystalline particles.

Manual sieve analysis

Sieve Size (μm)

Weight (g)

By weight [%]

Sieve

Sieve & Powder

Powder

>1000

369.0

395.1

26.1

26.1

850-1000

378.5

384.7

6.2

6.2

<850

242.0

309.7

67.7

67.7

Laser diffraction particle size analysis

- Full Test Results (sample tested: < 850 µm)

 

RUN 1

RUN 2

RUN 3

Average

Volume %

100.0

100.0

100.0

100.0

Mean (µm)

284.8

285.7

254.4

274.5

Median (µm)

440.2

438.4

391.7

423.8

Mode (µm)

716.7

716.7

716.7

716.7

95% Conf. Limit (µm)

26-3120

26.2-3110

21.4-3030

24.4-3090

S.D.

3.39

3.38

3.54

3.44

Applicant's summary and conclusion

Conclusions:
According to BS ISO 13320-1: 1999 and GLP principles the particle size distribution of the substance was determined using laser diffraction analysis, after manual sieving. The sample analysed was < 850 µm and was 67.7% by weight of the test substance. The median D50 of the analysed sample was 423.8 µm; 90% of all particles were < 784.4 µm and 3.09 % by volume of the analysed sample was seen to be ≤ 10.00 μm.